Information
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Document No.
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel/ Operator(s)
INFO
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Product Number:
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Formula Number:
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Work Order / Job Number:
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Batch/Lot Code:
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Expiration Date
Step 1 – Obtain Packaging Bill of Materials from job paperwork. Verify that packaging components on line match the bill of materials and are in good condition for use. Record any discrepancies below.
5P PACKAGING AUDIT
Paperwork (Organization). (Manufacturing Instructions and Quality Forms)
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Line Start Up Documentation Complete (Were the required line checks completed prior to the start of the run / Were the checks documented as being acceptable?)
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Pack Sheet / Record correctly filled out (Is the documentation for the job filled out completely? / Is the documentation up to date? Are appropriate sections verified as required? /Does data show that process is running inside of specification limits?)
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Components checked before/during run as required (Was each container (box, pallet, roll, etc.) of printed packaging components checked for label revision number prior to use? Are part / lot numbers recorded when required?)
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Quality equipment verified prior to start of run (Were all quality control devices (check weighers, cap detectors, etc.) verified prior to use? Were the checks documented on the production records?)<br>
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Quality / SPC data collection up to date (Is required quality data being collected? Is the data being recorded on production documentation or quality system as required?)
Packaging Components (Line Clearance). (Containers, Closures, Labels, Cartons & Pallets)
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Correct product container (bottle, bag, drum, etc) – Review the product being produced on the line. Verify that the part number of the container on the line matches the production documentation (pack sheet / record)
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Correct closure(s), fitments, sprayers, plugs, etc.– Review the product being produced on the line. Verify that the part number of the closures, etc. on the line matches the production documentation (pack sheet / record)
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Correct labels– Review the product being produced on the line. Verify that the part number / revision of the labels on the line matches the production documentation
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Correct outer container– Review the product being produced on the line. Verify that the part number / revision of the outer container on the line matches the production documentation (pack sheet / record)
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Materials on line for current job only – Verify that packaging components at the line are for the current job. No other packaging materials should be in the area.
Packaging Process. (Filling and Closing)
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Is the operator checking container fill weights – Is there evidence of periodic fill weight verifications? Verify that scale is set up correctly – tared out if required
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Is the operator checking closure torques – Is there evidence of closure torque verifications?
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Is the operator checking the average pallet weights (if required) – Is there evidence of average pallet weight verifications?
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Are the quality control devices working correctly? – Verify that quality control devices (check weighers and cap detectors) are working. Utilitze the test containers to verify that out of specification containers are detected and rejected if applicable
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Is the operator performing other quality checks as specified – Is there evidence of other quality check verifications?
Packaged Product Appearance. (Finished Product)
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Drips on Container / Flexible Container Seals – Review the product produced on the line for drips on containers. Review a minimum of 10 containers or 1 pallet of product whichever is less. For flexible containers inspect seals and welds for defects
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Closures (including nozzles, pumps, tamper seals, etc) – present, secure, not crooked, etc. – Review the product being produced on the line for missing, crooked or non-secure closures. Review a minimum of 10 containers or 1 pallet of product whichever is less.
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Label Appearance – correct location, no wrinkles, smears, etc. – Review the product produced on the line for label appearance. Review a minimum of 10 containers or 1 pallet of product whichever is less.
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Correct date code – applied correctly and legible – Review the product produced on the line for proper date coding of containers. Review a minimum of 10 containers or 1 pallet of product whichever is less.
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Quality pallet used – cracked / missing boards and nails protruding – Review the product being produced on the line. Observe pallets for cracked or missing boards. Observe pallets for nails protruding above boards. Review 5 pallets on line if available.
Packaging Equipment and Tools. (Putting It Together)
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Are quality control devices working as designed – Look for evidence of the quality control devices (check weighers, cap detection, etc.) identifying defects.
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Does the filling equipment drip product after shut off – Observe package filling equipment and note any sustained leaks or drips after the equipment is shut off. Are automatic drop trays working correctly?
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Is the filling line working properly – i.e. no jams, miss-fills, etc. – Observe line for package jams, miss-fills, product damage, etc.
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Is the product palletized correctly – Review the pallet pattern on the corrugated box or in the production documentation. Is the product packaged according to the specified pattern – cases per layer, layers per pallet and case orientation?
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Are the quality tools (wrenches, scales, etc.) calibrated – Are the quality tools (wrenches, scales, etc.) calibrated? Is the calibration expired?
